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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET INC. M2A 38MM CUP PROSTHESIS, HIP

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BIOMET INC. M2A 38MM CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Explanted; Replace
Event Date 09/25/2008
Event Type  Injury  
Event Description

It was reported that patient underwent hip procedure in 2004. Subsequently, patient underwent revision procedure in 2008, due to severe pain. During procedure clear fluid and necrosis tissue were noted. Acetabular cup shell and modular head components were replaced.

 
Manufacturer Narrative

The user facility is outside of the united states. No medwatch report was received. No user facility information is available. Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur.

 
Event Description

It was reported that patient underwent hip procedure in 2004. Subsequently, patient underwent revision procedure (b) (6) 2008 due to severe pain. During procedure, clear fluid and necrosis tissue were noted. Acetabular cup shell and modular head components were replaced.

 
Manufacturer Narrative

The component was never returned to manufacturer, but sent to a third party for evaluation. A report was forwarded by third party evaluator to biomet and reviewed by a research scientist. The third party evaluation summary states "the cup inclination was thirty degrees, version not measured. Wear and cocr ion release were higher than typical". The report offers no explanation of the findings and the photographs were taken at too low a magnification to determine any root cause.

 
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Brand NameM2A 38MM CUP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET INC.
p.o. box 587
warsaw IN 46581 058
Manufacturer (Section G)
BIOMET INC.
p.o. box 587
warsaw IN 46581 058
Manufacturer Contact
kim walgamuth
p.o. box 587
warsaw , IN 46581-0587
5742676639
MDR Report Key1206663
Report Number1825034-2008-00275
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date12/31/2013
Device MODEL NumberN/A
Device Catalogue NumberRD118850
Device LOT Number547300
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/26/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 10/23/2008 Patient Sequence Number: 1
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